(157 days)
The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.
AccuBind™ Neo-Natal T4 Microplate EIA
The provided text is a 510(k) premarket notification approval letter for a medical device (AccuBind™ Neo-Natal T4 Microplate EIA) and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This type of regulatory document confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed scientific study data or performance metrics you've requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information (points 1-9) would typically be found in a separate submission document or a scientific publication related to the device's validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 2 2003
Dr. Jay Singh Consultant, Regulatory Affairs Monobind. Inc. 729 West 16th Street, Suite C-4 Costa Mesa, CA 92627
Re: K030860
Trade/Device Name: AccuBind™ Neo-Natal T4 Microplate EIA Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI Dated: June 27, 2003 Received: July 1, 2003
Dear Dr. Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K030860
Device Name: AccuBind™ Neo-Natal T4 Microplate ElA
The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
OR
Over-The-Counter (OTC) Use
(Per 21CFR 801.109)
(Optional Format 1-2-96).
Carol C Benson for Jean Cooper, Dr
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030860
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.